MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-10-23 for OHMEDA OXYGEN OUTLET DIAMOND 221-7810-814 manufactured by Medaes Inc. (formerly Ohmeda Medical Engineering Systems).
[15678143]
Device may have contributed to pt's demise by allowing the introduction of air into the abdomen. The event may be attributable to operator error. The operator may have connected vacuum regulator to wall oxygen outlet. However, it has yet to be determined why the gas did not escape through the esophagus and oral route. The pt sustained a cardiac arrest after the possible error.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 193245 |
| MDR Report Key | 193245 |
| Date Received | 1998-10-23 |
| Date of Report | 1998-10-20 |
| Date of Event | 1998-09-26 |
| Date Facility Aware | 1998-10-13 |
| Report Date | 1998-10-20 |
| Date Reported to FDA | 1998-10-20 |
| Date Reported to Mfgr | 1998-10-20 |
| Date Added to Maude | 1998-10-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OHMEDA OXYGEN OUTLET |
| Generic Name | "DIAMOND" FLUSH TYPE OUTLET, RECESSED |
| Product Code | CCN |
| Date Received | 1998-10-23 |
| Model Number | DIAMOND |
| Catalog Number | 221-7810-814 |
| Lot Number | N/I |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 32 YR |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 187767 |
| Manufacturer | MEDAES INC. (FORMERLY OHMEDA MEDICAL ENGINEERING SYSTEMS) |
| Manufacturer Address | 2850 COLONNADES COURT NORCROSS GA 30071 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 1 | 1. Death | 1998-10-23 |